Spironolactone 25mg Tablets
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SPIRONOLACTONE 25 mg & 100 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Spironolactone is for
2. Before you take Spironolactone
3. How to take Spironolactone
4. Possible side effects
5. How to store Spironolactone
6. Further information
1. WHAT SPIRONOLACTONE IS FOR
Spironolactone belongs to a group of medicines called diuretics (water tablets).
Spironolactone can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can be due to:
• congestive heart failure causing swollen ankles or shortness of breath
• nephrotic syndrome (a kidney disorder)
• hepatic cirrhosis (liver disease) causing ascites (build up of fluid in your abdomen) or oedema (build up of fluid in your body causing swelling of the arms, hands, legs or feet)
• malignant ascites (a condition in which fluid containing cancer cells collect in your abdomen)
• primary aldosteronism (a condition in which your adrenal glands release too much of the hormone aldosterone)
• hypertension (high blood pressure) due to primary aldosteronism.
Spironolactone works by helping you to pass more water (urine) than you usually do.
2. BEFORE YOU TAKE SPIRONOLACTONE
Do not take Spironolactone and tell your doctor if you
• are allergic to Spironolactone or any of the other ingredients in the tablets (listed in section 6 of this leaflet)
• have Addison's disease. This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure
• have severe kidney problems
• have high blood levels of potassium
• have low blood levels of sodium
• are not passing any water (urine).
Take special care with Spironolactone
Tell your doctor before you take this medicine if you
• have liver or kidneys problems
• suffer from porphyria (an inherited iron disorder).
Regular blood and urine tests may be needed to monitor your fluid and electrolyte (e.g. potassium and sodium) levels, especially if you are elderly or have liver or kidneys problems.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Spironolactone tablets work:
• Other diuretics such as Amiloride or Triamterene
• Medicines or supplements containing potassium (including table salt substitutes)
• Medicines to treat heart failure or irregular heartbeats such as Digoxin, Digitoxin or Eplerenone
• Medicines to treat high blood pressure such as Captopril, Candesartan, Clonidine, Guanethidine, Doxazosin, Atenolol, Amlodipine or Sodium Nitroprusside. Your doctor may need to change the dose of your medicine
• Medicines to treat chest pain such as Glyceryl Trinitrate
• Medicines for depression or mental health problems such as Lithium, Amisulpride, Pimozide, Sertindole, Amitriptyline, Moclobemide or Prochlorperazine
• Medicines to calm you down or to help you sleep such as Diazepam
• Carbamazepine to treat epilepsy
• Trilostane for Cushings syndrome or breast cancer
• Ciclosporin or Tacrolimus to stop the rejection of organs after transplants
• Cisplatin to treat various types of cancer
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Aspirin, Ibuprofen or Ketorolac for pain and swelling
• Chlorpropramide to treat diabetes
• Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies
• Oestrogens for contraception or hormone replacement therapy.
Spironolactone does not cause loss of potassium from your body as other water tablets do. Therefore, it is not necessary for you to get extra potassium in your diet or take supplements. Too much potassium could even be harmful.
AVOID ALCOHOL whilst taking this medicine.
If you are going to have an operation where you will be given an anaesthetic, tell the doctor in charge that you are taking Spironolactone.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning a pregnancy or are breast-feeding. Make sure you follow your doctor's advice.
Driving and using machines
Spironolactone may cause drowsiness or dizziness. If affected do not drive or operate machinery.
3. HOW TO TAKE SPIRONOLACTONE
Always take Spironolactone tablets exactly as your doctor has told you. Take this medicine once a day with a meal.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition.
Adults:
The usual adult dose varies from 25-200 mg once a day.
Elderly:
Your doctor may start you on a low starting dose and gradually increase the dosage as needed to obtain the desired effect.
Children:
Your doctor will work out the number of tablets that you should give to your child, as it depends on your child's weight. The tablets can be crushed and taken with food or drink if necessary.
If you take more Spironolactone than you should
Contact your doctor or go to a hospital immediately. Take the package or container with you. Symptoms of an overdose may include drowsiness, dizziness, confusion, nausea, vomiting or diarrhoea.
If you forget to take Spironolactone
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Spironolactone DO NOT STOP taking Spironolactone until your doctor tells you to. If you stop taking the tablets too soon, your condition may get worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Spironolactone tablets can cause side effects, although not everybody gets them.
If you have an allergic reaction to Spironolactone see a doctor straight away
An allergic reaction may include:
• skin rash, redness, itching or hives
• swelling of the face, lips, mouth or throat
• difficulty in breathing or swallowing.
If you get any of the following side effects, STOP TAKING Spironolactone and see your doctor as soon as possible:
• high blood levels of potassium, which can cause muscle weakness, tiredness or irregular heartbeats
• low blood levels of sodium, which can cause tiredness, confusion, muscle cramps, fits or coma
• liver damage, which can cause yellowing of the skin or whites of the eyes (jaundice)
• kidney damage, which can cause dehydration, loss of appetite, aches and pains in the stomach area or blood in your urine
• blood disorders, which can cause unexplained bleeding, bruising, sore throat, general illness or fever.
The side effects mentioned above may alter the results of blood and urine tests.
Other side effects include:
• headache, dizziness, tiredness or confusion
• stomach upsets, nausea, vomiting or diarrhoea
• breast enlargement in men (this usually goes away when treatment is stopped)
• inability to achieve or maintain an erection (impotence)
• menstrual problems in women
• soft bones
• increase in the number of times and the amount of water (urine) you pass. This may be due to the medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via yellow card scheme website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SPIRONOLACTONE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Spironolactone tablets contain
The active ingredient in Spironolactone 25 mg and 100 mg tablets is spironolactone. The other ingredients are calcium sulphate dihydrate, maize starch, crospovidone, povidone, pregelatinised starch, magnesium stearate, peppermint flavour (peppermint oil and starch) and quinoline yellow (E104).
What Spironolactone tablets look like and contents of the pack
The 25 mg tablets are pale yellow tablets with the marking MP28 on one side. The 100 mg tablets are pale yellow tablets with the marking MP29 on one side. Both strengths have a peppermint odour.
The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstrasse 7,
12347 Berlin, Germany
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 02/2015
M0028-0029/O/PIL1/M1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRONOLACTONE 25 mg & 100 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Spironolactone is for
2. Before you take Spironolactone
3. How to take Spironolactone
4. Possible side effects
5. How to store Spironolactone
6. Further information
1. WHAT SPIRONOLACTONE IS FOR
Spironolactone belongs to a group of medicines called diuretics (water tablets).
Spironolactone can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can be due to:
• congestive heart failure causing swollen ankles or shortness of breath
• nephrotic syndrome (a kidney disorder)
• hepatic cirrhosis (liver disease) causing ascites (build up of fluid in your abdomen) or oedema (build up of fluid in your body causing swelling of the arms, hands, legs or feet)
• malignant ascites (a condition in which fluid containing cancer cells collect in your abdomen)
• primary aldosteronism (a condition in which your adrenal glands release too much of the hormone aldosterone)
• hypertension (high blood pressure) due to primary aldosteronism.
Spironolactone works by helping you to pass more water (urine) than you usually do.
2. BEFORE YOU TAKE SPIRONOLACTONE
Do not take Spironolactone and tell your
doctor if you
• are allergic to Spironolactone or any of the other ingredients in the tablets (listed in section 6 of this leaflet)
• have Addison's disease. This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure
• have severe kidney problems
• have high blood levels of potassium
• have low blood levels of sodium
• are not passing any water (urine).
Take special care with Spironolactone
Tell your doctor before you take this medicine if you
• have liver or kidneys problems
• suffer from porphyria (an inherited iron disorder).
Regular blood and urine tests may be needed to monitor your fluid and electrolyte (e.g. potassium and sodium) levels, especially if you are elderly or have liver or kidneys problems.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Spironolactone tablets work:
• Other diuretics such as Amiloride or Triamterene
• Medicines or supplements containing potassium (including table salt substitutes)
• Medicines to treat heart failure or irregular heartbeats such as Digoxin, Digitoxin or Eplerenone
• Medicines to treat high blood pressure such as Captopril, Candesartan, Clonidine,
Guanethidine, Doxazosin, Atenolol, Amlodipine or Sodium Nitroprusside. Your doctor may need to change the dose of your medicine
• Medicines to treat chest pain such as Glyceryl Trinitrate
• Medicines for depression or mental health problems such as Lithium, Amisulpride,
Pimozide, Sertindole, Amitriptyline, Moclobemide or Prochlorperazine
• Medicines to calm you down or to help you sleep such as Diazepam
• Carbamazepine to treat epilepsy
• Trilostane for Cushings syndrome or breast cancer
• Ciclosporin or Tacrolimus to stop the rejection of organs after transplants
• Cisplatin to treat various types of cancer
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Aspirin, Ibuprofen or Ketorolac for pain and swelling
• Chlorpropramide to treat diabetes
• Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies
• Oestrogens for contraception or hormone replacement therapy.
Spironolactone does not cause loss of potassium from your body as other water tablets do. Therefore, it is not necessary for you to get extra potassium in your diet or take supplements. Too much potassium could even be harmful.
AVOID ALCOHOL whilst taking this medicine.
If you are going to have an operation where you will be given an anaesthetic, tell the doctor in charge that you are taking Spironolactone.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning a pregnancy or are breastfeeding. Make sure you follow your doctor's advice.
Driving and using machines
Spironolactone may cause drowsiness or dizziness. If affected do not drive or operate machinery.
3. HOW TO TAKE SPIRONOLACTONE
Always take Spironolactone tablets exactly as your doctor has told you. Take this medicine once a day with a meal.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition.
Adults:
The usual adult dose varies from 25-200 mg once a day.
Elderly:
Your doctor may start you on a low starting dose and gradually increase the dosage as needed to obtain the desired effect.
Children:
Your doctor will work out the number of tablets that you should give to your child, as it depends on your child's weight. The tablets can be crushed and taken with food or drink if necessary.
If you take more Spironolactone than you should
Contact your doctor or go to a hospital immediately. Take the package or container with you. Symptoms of an overdose may include drowsiness, dizziness, confusion, nausea, vomiting or diarrhoea.
If you forget to take Spironolactone
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Spironolactone DO NOT STOP taking Spironolactone until your doctor tells you to. If you stop taking the tablets too soon, your condition may get worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Other side effects include:
• headache, dizziness, tiredness or confusion
• stomach upsets, nausea, vomiting or diarrhoea
• breast enlargement in men (this usually goes away when treatment is stopped)
• inability to achieve or maintain an erection (impotence)
• menstrual problems in women
• soft bones
• increase in the number of times and the amount of water (urine) you pass. This may be due to the medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via yellow card scheme website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE SPIRONOLACTONE
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, Spironolactone tablets can cause side effects, although not everybody gets them.
If you have an allergic reaction to Spironolactone see a doctor straight away
An allergic reaction may include:
• skin rash, redness, itching or hives
• swelling of the face, lips, mouth or throat
• difficulty in breathing or swallowing.
If you get any of the following side effects, STOP TAKING Spironolactone and see your doctor as soon as possible:
• high blood levels of potassium, which can cause muscle weakness, tiredness or irregular heartbeats
• low blood levels of sodium, which can cause tiredness, confusion, muscle cramps, fits or coma
• liver damage, which can cause yellowing of the skin or whites of the eyes (jaundice)
• kidney damage, which can cause dehydration, loss of appetite, aches and pains in the stomach area or blood in your urine
• blood disorders, which can cause unexplained bleeding, bruising, sore throat, general illness or fever.
The side effects mentioned above may alter the results of blood and urine tests.
What Spironolactone tablets contain
The active ingredient in Spironolactone 25 mg and 100 mg tablets is spironolactone. The other ingredients are calcium sulphate dihydrate, maize starch, crospovidone, povidone, pregelatinised starch, magnesium stearate, peppermint flavour (peppermint oil and starch) and quinoline yellow (E104).
What Spironolactone tablets look like and contents of the pack
The 25 mg tablets are pale yellow tablets with the marking MP28 on one side. The 100 mg tablets are pale yellow tablets with the marking MP29 on one side. Both strengths have a peppermint odour.
The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
Haupt Pharma Berlin GmbH,
Moosrosenstrasse 7, 12347 Berlin, Germany
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 02/2015
M0028-0029/O/PIL2/M1